510(k) K822870
K822870 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "STOOL-COLLECTION/PRESERVATION KIT". The FDA issued a decision of Substantially Equivalent on November 1, 1982. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. American Scientific Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1982
- Date Received
- September 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Specimen Mailer And Storage, Sterile
- Device Class
- Class I
- Regulation Number
- 864.3250
- Review Panel
- PA
- Submission Type